Chronic Renal FailurePhase 1/2NCT01152411
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Chronic Renal Failure
A Phase 1/2 study testing Autologous bone marrow stem cells in people with Chronic Renal Failure, run by International Stemcell Services Limited at 1 site in India.
Trial summary
Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Autologous bone marrow stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2010to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to give voluntary written (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- CKD patients of stage IV and ESRD with age 18 to 65 years.
- Patient should be afebrile 24 hours prior to procedure.
Who cannot join
- Women who are pregnant or lactating
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Haemoglobin level below 8g %
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Known bleeding or coagulation disorder.
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- Known hematologic disease
- Poorly controlled hypertension
- Evidence of active malignancy within one year prior to randomization.
- Severe skin infection or osteomyelitis - the site of bone marrow aspiration potentially limiting the procedure.
- Have a known allergy to iodinated contrast
- Positive test results for HIV and AIDS complex, HCV, HbsAg and Syphilis.
- History of drug or alcohol abuse
- Patients on immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Autologous Bone Marrow Stem Cell Transplantation in the Treatment of Chronic Renal Failure in 5 Indian Patients - ABMST-CRF Study (Autologous Bone Marrow Stem Cell Transplantation-CRF)
Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum.
CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery).
Read more
In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health.
In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.
- Conditions
- Chronic Renal Failure
- Being tested
- Autologous bone marrow stem cells
- Keywords
- Renal Failure, Chronic Kidney Disease, Chronic Renal Failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow stem cellsOther
Bone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Not described Receives: Other: Autologous bone marrow stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%)
Measured: 1 year
Number of patients reporting adverse effects as a measure of safety and tolerability
Measured: 1 year
Secondary outcomes (1)
Improvement in renal biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Stemcell Services Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balakrishna S, M.B.B.S, Study director, International Stemcell Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152411
- Sponsor's protocol ID
- ISSL-AuBM-CRF
- Status last verified
- Mar 2012
- First submitted
- 26 Jun 2010
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Bone Marrow Stem Cell Transplantation in the Treatment of Chronic Renal Failure in 5 Indian Patients - ABMST-CRF Study (Autologous Bone Marrow Stem Cell Transplantation-CRF)
- ClinicalTrials.gov ID
- NCT01152411
- Acronym / sponsor ID
- ISSL-AuBM-CRF
- Conditions
- Chronic Renal Failure
- Keywords
- Renal Failure, Chronic Kidney Disease, Chronic Renal Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- International Stemcell Services LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic renal failure (CRF, or "chronic kidney failure", CKF, or "chronic kidney disease", CKD) is a slowly progressive loss of renal function over a period of months or years and defined as an abnormally low glomerular filtration rate, which is usually determined indirectly by the creatinine level in blood serum.
CRF that leads to severe illness and requires some form of renal replacement therapy(such as dialysis) is called end-stage renal disease (ESRD). While renal replacement therapies can maintain patients indefinitely and prolong life, the quality of life is severely affected. Renal transplantation increases the survival of patients with stage 5 CKD significantly when compared to other therapeutic options; however, it is associated with an increased short-term mortality (due to complications of the surgery).
In view of the above, there is definitely an urgent need for finding different methods of treatment for these patients who cannot undergo established modalities of treatment or these have been tried unsuccessfully hence the inadequacy of current treatment modalities and insufficiency of donor organs for transplantation have driven a search for improved methods of dealing with renal failure. The rising concept of cell-based therapeutics has provided a framework around which new approaches are being generated, and its combination with advances in stem cell research stands to bring both fields to clinical fruition. Since CRF affects a large number of these patients who will lose their productive life, stem cell implantation can offer some promise of improved health.
In our present study, we want to evaluate the safety and efficacy (to know / observe for Proof of concept in five indian patients) if any, of autologous bone marrow derived stem cells injected into the Renal Artery in five (initially five patients, can be increased to ten patients after observing the initial results) patients with Chronic Renal Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Other: Autologous bone marrow stem cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be able to give voluntary written (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- CKD patients of stage IV and ESRD with age 18 to 65 years.
- Patient should be afebrile 24 hours prior to procedure.
Key exclusion criteria (14 listed)
- Women who are pregnant or lactating
- Acute Renal Failure
- Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Haemoglobin level below 8g %
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bone marrow stem cellsBone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery. | Other | Autologous bone marrow stem cells |
Primary outcome
Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%)
Time frame: 1 year
Number of patients reporting adverse effects as a measure of safety and tolerability
Time frame: 1 year
1 secondary outcome
Improvement in renal biopsy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balakrishna S, M.B.B.S study director
International Stemcell Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous bone marrow stem cells in people with Chronic Renal Failure, run by International Stemcell Services Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant clinical improvement in serum creatinine and urine output (improvement in measured GFR by 50%) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.